Kornimate/medical-research-clean huggingface dataset:
athenas - retrospective study of compliance in chronic hepatitis c with pegylated interferon alfa-2b/ribavirin in brazil (p05632)

Conditions: Hepatitis C, Chronic

Summary: this is a phase 4, retrospective and observational, multicenter, national (brazil), open, noncomparative, and nonrandomized study, which does not have visits. this study will be conducted in accordance to good clinical practices. the procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis c with peginterferon alfa-2b and ribavirin. this review will take place after the subjects have signed the informed consent form authorizing collection of these data. the collection of data for virological response after week 12 will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

this is a phase 4, retrospective and observational, multicenter, national (brazil), open, noncomparative, and nonrandomized study, which does not have visits. this study will be conducted in accordance to good clinical practices. the procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis c with peginterferon alfa-2b and ribavirin. this review will take place after the subjects have signed the informed consent form authorizing collection of these data. the physician will be filling out the case report form with the information contained in the medical record. any dose reduction and/or doses not taken during this period will be reported through the case report form. the collection of data for virological response after week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

Eligibility criteria:
inclusion criteria: * must have confirmed his/her willingness in participating in this study, after having been informed of all aspects that are pertinent to his/her decision to participate, by signing and dating the informed consent form (icf) approved by the institutional review board / independent ethics committee on research (irb/iec). * adult patients who are 18 years old or above. * must have diagnosis of chronic hepatitis c confirmed through positive qualitative or quantitative pcr (polymerase chain reaction) performed prior to initiation of the patient's treatment. this result shall be documented in the patient's records. * must have completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. * patients who started treatment for chronic hepatitis c from the year 2008 or later. exclusion criteria: * does not confirm his/her willing in participating in this study or refuses to sign the informed consent form. * did not start the treatment with peginterferon alfa-2b and ribavirin. * patients who have less than 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
a low-carbohydrate, ketogenic diet versus orlistat for weight loss

Conditions: Diabetes Mellitus; Obesity

Summary: this study compares two types of diet interventions: a low carbohydrate ketogenic diet (atkins) and a low-fat diet combined with a medication (orlistat).

overweight and obesity are increasingly prevalent in the veteran population as well as the general public. for patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. the purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (atkins) with a combination of a low-fat diet and orlistat. the outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. this is a randomized, parallel-intervention trial. subjects (n=150) will be recruited from the durham vamc ambulatory care clinics. all patients receive one of the two intensive weight loss interventions.

Eligibility criteria:
inclusion criteria: * participants must have a va medical center primary care provider; * failed first line diet and exercise recommendations; * in stable health by screening physical and lab tests; * agrees to make regular visits per study protocol; * has access to telephone; * body mass index (bmi) \> or = 27 with obesity-related illness or bmi \> or = 30 with no risk factors; * no contraindications to orlistat; * not pregnant or breast-feeding; * no serious mental health illness such as dementia or schizophrenia; * no use of a weight loss therapy in the month prior to screening. exclusion criteria: * no vamc primary care provider * unable to attend regular study visits * no access to telephone * bmi \< 27 * contraindications to orlistat * pregnancy, breast feeding or planning to become pregnant * unstable mental health illness * use of a weight loss therapy in the month prior to screening

Keywords: anti-obesity agents diet therapy diet, reducing obesity overweight risk factors weight loss
eribulin mesylate and cisplatin in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: this trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more tumor cells.

primary objectives: i. to determine the maximum tolerated dose of e7389 and cisplatin in patients with advanced solid tumors. ii. to determine the safety and toxicity of this regimen in these patients. iii. to determine the pharmacokinetics of this regimen in these patients. outline: this is a multicenter, dose-escalation study. patients receive eribulin mesylate iv over 5 minutes on days 1, 8, and 15 and cisplatin iv over 30-60 minutes on day 1. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed for up to 8 weeks.

Eligibility criteria:
inclusion criteria: * histologically confirmed malignant solid tumor * advanced disease, meeting both of the following criteria: metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective. * no known active brain metastases * life expectancy \> 3 months * ecog performance status 0-2 * bilirubin normal * no uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit study compliance. * negative pregnancy test * fertile patients must use effective contraception * recovered from prior therapy * no prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin c). * no prior targeted therapy within the past 4 weeks * no prior immunotherapy within the past 4 weeks * no prior radiotherapy within the past 4 weeks. * no more than 2 prior chemotherapy regimens for advanced solid tumors. * no other concurrent investigational agents. bisphosphonate therapy (e.g., pamidronate or zolendronate) is not considered investigational therapy. * no concurrent antiretroviral therapy for hiv-positive patients. * no other concurrent anticancer agents or therapies. * tumor has spread to other parts of the body or cannot be removed by surgery. * more than 4 weeks since chemotherapy, biological therapy, or radiation therapy. * no more than two previous chemotherapy regimens for advanced solid tumor. * wbc \>= 3,000/mm\^3 * platelet count \>= 100,000/mm\^3 * creatinine clearance \>= 60 ml/min * absolute neutrophil count \>= 1,500/mm³ * ast and alt =\< 2.5 times upper limit of normal * no prior cumulative cisplatin dose \> 300 mg/m\^2 * no preexisting neuropathy \<= grade 2 * not pregnant or nursing
quality of life assessment between internal endoscopic versus percutaneous drainage in biliary obstruction

Conditions: Biliary Obstruction

Summary: the aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ercp) and/or percutaneous trans-hepatic biliary drainage (ptbd).


Eligibility criteria:
inclusion criteria: * patients with benign biliary obstruction * patients with malignant biliary obstruction * patients undergoing ercp and/or ptbd exclusion criteria: * patients with gallstone disease * patients who will undergo ercp who have previously underwent a ptbd * patients who will undergo ptbd who have previously underwent an ercp * female patients who are pregnant * prisoners and other vulnerable populations
clinical trial of nac in asthma

Conditions: Asthma

Summary: this study evaluates 20% n-acetylcystine (nac) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by ct imaging. the study is a crossover design, which means that half the study participants will get 20% nac in the first 7-day treatment period and placebo in the next 7-day treatment period; and the other half will get placebo in the first 7-day treatment period and 20% nac in the next 7-day treatment period.

n-acetylcystine (nac) is a mucolytic medication, meaning that it breaks apart mucus. investigators know that mucus is a factor in severe asthma attacks. however, mucus may be a factor in chronic severe asthma as well. this role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. using a novel approach of scoring mucus occlusion, investigators have used ct imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs. historically, studies of mucolytics, like nac, have not shown benefit in other obstructive lung diseases, like copd. however, utilizing ct mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction. this is a randomized, double-blind, placebo-controlled phase 4 study of 20% nac in patients with asthma who also have evidence of mucus in their lungs as determined by ct imaging. investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like nac, will result in an improvement of lung function.

Eligibility criteria:
inclusion criteria: * able to perform reproducible spirometry according to ats criteria * clinical history consistent with moderate to severe asthma for 1 year or greater. * post-bronchodilator fev1 \<90% of predicted * prescription and daily use of inhaled corticosteroid (ics) equivalent to 240mcg of beclomethasone or greater and a second asthma controller therapy. * ct mucus score \>3 (determined during the initial screening process, provided the prior two conditions are met) * written informed consent obtained from participant and ability for participant to comply with the requirements of the study. exclusion criteria: * pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * history of intolerance to study medications. * current use of carbamazepine * angina which includes a treatment plan with prn nitroglycerin or nitrites * smoking of tobacco or other recreational inhalants in last year and/or \>10 pack-year smoking history * current participation in an investigational drug trial concurrent medications
suturing techniques for vesico-urethral anastomosis

Conditions: Prostate Cancer Surgery

Summary: radical prostatectomy (rp) is the most common curative treatment for prostate cancer (pca).vesicourethral anastomosis (vua) is a crucial step and either a conventional interrupted (is) or a running (rs) suture is employed during radical prostatectomy (rp). certainly, both rs and is have advantages and limitations. the metanalysis revealed that potential advantages for rs compared to is, especially for short-term outcomes such as catheterization time, extravasation rate, and anastomotic suture time. there were no significant differences for long-term outcomes (continence, incidence of vesicourethral anastomotic stenosis). generally, the exciting evidence suggests that cs should be preferred over is. however, this should be followed only if it is technically feasible and appropriate regarding the surgical approach. both techniques seem to be safe and appropriate for the vua, and the technique should be chosen based on individual experience and preference. the investigators hypothesized that rs and is may have different effects on voiding function and flow rate, even if they do not cause an anastomotic stenosis requiring intervention. furthermore, there is no existing literature that compares rs and is in terms of voiding function.this article focuses on one year uroflowmetric voiding parameters, urinary function (uf), and uf related bother function, urinary continence recovery as well as other secondary outcomes, including surgical parameters, perioperative morbidity and oncological outcomes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of clinically localised (pt1-pt2) prostate cancer * must select the open radical prostatectomy procedure as a treatment option. exclusion criteria: * history of acute urinary retention * history of urethral stricture

Keywords: prostate cancer vesicourethral anastomosis voiding function suture
vr-pat for pain and anxiety management during pediatric dermatologic laser procedures

Conditions: Procedural Anxiety; Procedural Pain

Summary: this study will assess the feasibility and efficacy of our virtual reality pain alleviation therapy (vr-pat) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of vr use on reducing anxiety in patients undergoing dermatologic laser procedures. the investigators hypothesize that patients using vr-pat will report less pain and anxiety during the laser procedure than patients who do not play the game.

in this two-group crossover randomized clinical trial, patients will be randomly assigned to either the vr-pat intervention group or control group (same vr google without game) at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. survey questions to assess pain and anxiety and control for confounding factors will be asked before and after each procedure.

Eligibility criteria:
inclusion criteria: * dermatology patients (5+ years) who are undergoing first laser procedure at the nationwide children's outpatient laser * have a legal guardian present for patients less than 18 years old for the procedure (for informed consent) * can communicate orally exclusion criteria: * any wounds that may interfere with study procedures * usage of a diode laser (vr safety has not been established yet) * vision, hearing, or cognitive/motor impairments preventing valid administration of study measures * history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras * minors in foster care * unable to communicate in english * pregnant women * prisoners

Keywords: laser dermatology virtual reality vr
the effect of case-based education on the development of nursing students' clinical reasoning skills

Conditions: Clinical Reasoning; Critical Illness

Summary: aim: this study was conducted to determine the effect of case-based education on the development of clinical reasoning skills of nursing students in critical illnesses. methods: the study was conducted between january 20 and june 30, 2021 using a pilot randomized controlled trial design. in the study, 22 volunteer students were assigned to the experimental and control groups by simple randomization. the experimental group was given case-based education to improve their clinical reasoning skills, and the control group continued the standard education process. data were collected using a student information form, the clinical reasoning case form (crcf), the student satisfaction with education questionnaire, and a form for views on the education. in the evaluation of data, frequency values, fisher exact test, mann-whitney u, and wilcoxon tests, cohen's d coefficient for effect size, itt analysis, and covariance analysis were used.

aim of the study this study was conducted to determine the effect of case-based education on the development of nursing students' clinical reasoning skills in critical illnesses. research hypotheses h01: there is no difference between the experimental group and the control group in terms of their crcf scores. h02: case-based education on clinical reasoning has no positive effect on student satisfaction.

Eligibility criteria:
inclusion criteria: * having completed the "medical nursing" and surgical nursing" courses, * volunteering to participate in the study, * participate in "case-based education" exclusion criteria: * not being willing to participate in the study, * abandoning the "case-based education" practice * not taking one or two of the "medical nursing" and "surgical nursing" courses at all, or to have taken them but unsuccessfully
cvi drug coated balloon first in human trial

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to assess safety and the inhibition of restenosis of the cvi paclitaxel-coated pta balloon catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (sfa) or popliteal arteries. the primary endpoint for this analysis is late lumen loss at six (6) months.

prospective, controlled, multi-center, open, single arm study main cohort: 50; pre-specified treatment group: 30. total patients: 80

Eligibility criteria:
inclusion criteria: * subjects with symptomatic leg ischemia, requiring treatment of sfa or popliteal (p1 segment) artery * de novo or restenotic lesion(s) \>70% within the sfa and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). * target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation). * rutherford classification of 2, 3 or 4 exclusion criteria: * lesion length is \ 15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured. * outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure. * treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.

Keywords: peripheral arterial disease
cft self-help for accessing cervical screening after sexual assault

Conditions: Trauma, Psychological; Sexual Violence; Cervical Cancer

Summary: the aim of this study is to evaluate the feasibility of a new self-help intervention designed to support individuals (anyone with a cervix) to access cervical cancer screening following the experience of sexual assault, by addressing psychological barriers identified by previous research, specifically shame, low self-efficacy and the re-traumatising nature of attending to sexual health after sexual trauma.

the study aims to investigate the acceptability, feasibility and limited efficacy of a discrete, easily accessed (mobile phone, tablet or computer) self-help intervention to support people to access cervical screening independently. the study will use a wait-list control design, with participants randomly allocated to receive access to the intervention immediately or after a six-week wait. the intervention will be in the form of a web app and will contain a range of psychoeducational material and practice exercises following a cognitive-behavioural and compassion-focused approach to understanding and coping with trauma, building self-compassion and increasing confidence in ability to attend and complete a screening.

Eligibility criteria:
inclusion criteria: * has a cevix * within age range for cervical cancer screening in uk (25-64 years) * experience of sexual assault (in childhood and/or adulthood; not within last 12 months) * currently experiencing difficulty attending cervical cancer screening * has access to smartphone/computer with internet * has a valid email address * able to read and understand english * living in uk exclusion criteria: * no cervix * outside of uk cervical cancer screening age range * no experience of sexual assault or sexual assault occurred within last 12 months * no access to smartphone or computer and internet * unable to read or understand english * not living in uk * in acute mental health crisis
remote state training for insomnia in older adults

Conditions: Insomnia

Summary: this study called rstate (remote state training for insomnia in older adults) is a phase ii study to definitively evaluate the efficacy of a computerized cognitive training program (rstate) designed to improve sleep regulation and brain health and extend functional independence in older adults with insomnia.


Eligibility criteria:
inclusion criteria: 1. participants who are 65 years of age or older. the inclusion age of ≥ 65 is in accordance with the fda's guideline for industry studies in support of special populations (geriatrics ich-e7), which uses 65 as its cutoff for defining the geriatric population prone to insomnia. 2. participants who have an insomnia disorder diagnosis per dsm-v. 3. participants who exhibit \> 30 minutes sleep onset latency (sol); and/or \> 30 minutes wake after sleep onset (waso). 4. participants must be a us resident. 5. participants who are fluent english speakers, per self-report, to ensure reasonable neuropsychological results on key assessments. 6. participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse or a tablet. exclusion criteria: 1. participants who score ≥ 4 on the cognitive function index (cfi). 2. participants who self-report vision or hearing difficulties that would interfere with the ability to complete the study tasks. 3. participants with past or present psychosis, schizophrenia, or bipolar disorder. participants with other untreated psychiatric disorder, including substance abuse/dependence disorders. 4. participants with a seizure disorder. 5. participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome). 6. participants with a recent hospitalization, ongoing chemotherapy or other cancer treatment. 7. participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment (cbti) in the last 12-months that could affect the outcome of this study, or concurrent engagement in another insomnia treatment, per self-report. however, participation in standard treatments not known to affect sleep (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable if stable on medications for \> 3 months. 8. participants who are using computer-based cognitive training programs or have used it within a month of the consent date.